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MHRA issues reminder about risks of fluoroquinolone antibiotics
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The Medicines and Healthcare products Regulatory Agency has reminded pharmacists and other health professionals to be aware of the serious side-effects of fluoroquinolone antibiotics and advise patients to stop taking them at the first sign of an adverse reaction.
The MHRA said systemic fluoroquinolones “can cause long-lasting, disabling and potentially irreversible side-effects, sometimes affecting multiple systems, organ classes and senses.” These, it said, can last months or years.
Adverse reactions can include tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy and central nervous system effects. The MHRA said patients’ doctors should be contacted “immediately” if any of these occur.
Fluoroquinolone antibiotics include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin and ofloxacin and they can go under another brand name.
The MHRA said the antibiotics should not be prescribed for non-severe or self-limiting infections or non-bacterial conditions such as non-bacterial (chronic) prostatitis. They should also not be prescribed for mild-to-moderate infections such as acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease unless other commonly recommended antibiotics are considered inappropriate.
The MHRA said “prescribing patterns” of fluoroquinolones in the UK have not changed even though it published restrictions and precautions on the drugs four years ago and has received reports of side-effects through its Yellow Card scheme.
In its latest guidance, the MHRA said ciprofloxacin or levofloxacin should not be prescribed for uncomplicated cystitis unless other commonly recommended antibiotics are considered inappropriate.
The regulator said fluoroquinolones should be avoided in patients who have had serious adverse reactions with a quinolone antibiotic such as nalidixic acid or a fluoroquinolone antibiotic.
Fluoroquinolones should also be prescribed “with special caution” for 60 year-olds and older and those with renal impairment or solid-organ transplants “because they are at a higher risk of tendon injury.”
The MHRA said a corticosteroid should not be used with a fluoroquinolone because “co-administration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture.”